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- Tasks: Support compliance auditing and monitoring to uphold high ethical standards.
- Company: Join Illumina, a leader in biotechnology with a commitment to innovation.
- Benefits: Enjoy flexible time off, private medical insurance, and employee stock purchasing.
- Why this job: Make a real impact in regulatory compliance within a dynamic industry.
- Qualifications: Experience in regulatory compliance or quality assurance in biotech or pharma.
- Other info: Opportunity for growth in a supportive and collaborative environment.
The predicted salary is between 36000 - 60000 £ per year.
Senior Analyst - Regulatory Compliance supports Illumina’s global compliance framework through the execution and continuous improvement of compliance auditing and monitoring activities. This role ensures that Illumina’s operations, quality systems, and regulatory programs meet applicable global requirements and uphold the company’s high standards of ethical and compliant conduct. This is an individual contributor role with no direct reports. The Senior Analyst may coordinate tasks or data collection efforts with colleagues and cross-functional stakeholders as needed.
Essential Duties and Responsibilities:
- Support compliance-related training activities and knowledge sharing across teams.
Key Competencies:
- Regulatory Knowledge: Understands core regulatory frameworks (FDA QSR, ISO 13485, EU MDR, GxP) and their relevance to internal audit and compliance functions.
- Accountability: Manages assigned audit and monitoring tasks independently while meeting established timelines.
Minimum Qualifications:
- Experience in regulatory compliance, quality assurance, or internal audit in the biotechnology, pharmaceutical, or medical device industry.
- Working knowledge of global regulatory standards such as FDA QSR (21 CFR Part 820), ISO 13485, EU MDR, and GxP.
- Experience supporting internal or external audits, inspections, or compliance monitoring activities.
- Strong organizational, communication, and documentation skills.
Preferred Qualifications:
- Experience with electronic Quality Management Systems (eQMS) or audit tracking tools.
- Familiarity with CAPA management and root cause analysis processes.
Other Requirements:
- Ability to travel domestically and internationally up to 10% of the time.
Senior Analyst - Regulatory Compliance in Cambridge employer: Illumina
Contact Detail:
Illumina Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Analyst - Regulatory Compliance in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory compliance field. Attend industry events or webinars, and don’t be shy about asking for informational interviews. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for those interviews by brushing up on your regulatory knowledge. Make sure you can discuss FDA QSR, ISO 13485, and EU MDR confidently. We want you to show off your expertise and how it aligns with Illumina’s high standards.
✨Tip Number 3
Practice your STAR technique for answering behavioural questions. Think of specific situations where you demonstrated accountability or managed compliance tasks independently. We want you to shine and show how you can contribute to the team!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive and engaged. Let’s get you that Senior Analyst role!
We think you need these skills to ace Senior Analyst - Regulatory Compliance in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in regulatory compliance and quality assurance. Use keywords from the job description to show that you understand what we're looking for.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Share specific examples of how you've supported compliance activities in the past and why you're excited about joining us at Illumina.
Showcase Your Regulatory Knowledge: Demonstrate your understanding of key regulatory frameworks like FDA QSR and ISO 13485. This will show us that you’re not just familiar with the terms, but you can apply them in real-world scenarios.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands and shows us you're serious about joining our team!
How to prepare for a job interview at Illumina
✨Know Your Regulations
Make sure you brush up on the core regulatory frameworks like FDA QSR, ISO 13485, and EU MDR. Being able to discuss these in detail will show that you understand their relevance to compliance and auditing, which is crucial for the Senior Analyst role.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed compliance tasks or audits. Highlighting your experience in the biotechnology or pharmaceutical industry will help demonstrate your fit for the position.
✨Communicate Clearly
Strong communication skills are key in this role. Practice articulating your thoughts clearly and concisely, especially when discussing complex regulatory topics. This will help you stand out as a candidate who can effectively share knowledge across teams.
✨Be Organised and Timely
Since the role requires managing tasks independently, be ready to discuss how you prioritise and organise your work. Bring examples of how you've met deadlines in previous roles, as this will showcase your accountability and time management skills.
